Sanmina-SCI earns quality certifications for Seven Medical Device Manufacturing Facilities
May 28, 2004
Independent testing agency, TUV Rheinland, verifies conformance to ISO 13485/88 Medical Device Manufacturing Quality Standards
Sanmina-SCI Corporation (Nasdaq: SANM) announced that seven of its medical device manufacturing facilities have been certified for ISO 13485 or 13488 as well as for CMDCAS (Canadian Medical Devices Conformity Assessment System) by TUV Rheinland of North America Inc., a global leader in compliance engineering and independent testing services. The TUV quality sanctions augment earlier facility registrations for all seven facilities by the USFDA (United States Food and Drug Administration).
According to John Hendrick, executive vice president of Sanmina-SCI's Medical Systems Division, ISO 13488 certifications have been granted to facilities located in Alabama, China, Ireland, Singapore and Sweden while ISO 13485 certifications have been granted to facilities in California and Israel. The Israel facility was granted ISO 13485 certification by the Standards Institute of Israel, which plans to transition its certification to TUV Rheinland later this year.
"Earning full compliance to international regulatory standards highlights our commitment to delivering highest quality medical device design, engineering and manufacturing services worldwide," said Hendrick. "By the end of the third quarter 2004, we expect to earn two more TUV certifications -- one for an additional facility in Alabama and another for a facility in Mexico -- which will expand TUV quality certifications to nine Sanmina-SCI medical facilities worldwide. "He noted that his division's superior quality control has been recognized by Frost & Sullivan, which recently selected Sanmina-SCI to receive the independent research organization's top award for product quality leadership.
"We are very pleased that Sanmina-SCI has chosen TUV Rheinland as its testing and registration service to certify its medical device manufacturing facilities," stated Stephan Schmitt, president and CEO of TUV Rheinland of North America. "Sanmina-SCI's commitment to the highest quality of manufacturing was highly evident in each one of the facilities that we independently tested and certified."
According to TUV Rheinland, the ISO 13485/13488 quality standards are specific to medical device quality systems and supplement the more generic ISO 9001 and 9002 standards that apply to many industries. Additional ISO 13485/13488 requirements include those that are critical in the medical device industry (e.g. special processes, design controls, process controls including environmental, traceability, record retention and regulatory actions).
TUV Rheinland also notes that the European Union (EU) has issued a number of "directives" that set forth compliance criteria for medical devices destined for the European market. These directives apply to a number of medical products, including active implantable medical and in vitro diagnostics devices. With its TUV Rheinland certifications, Sanmina-SCI is well positioned to comply with EU directives, since a significant portion of demonstrating EU compliance depends on the prior establishment and independent assessment of quality systems.